Creative Biolabs provides fully cGMP-compliant Viral Clearance Services with a wide selection of viral removal or viral inactivation processes, which is indispensable to demonstrate the safety of your cGMP manufacturing /cleaning processes. For each project, Creative Biolabs assembles a strong team of Ph.D. scientists with more than 20 years of experience, to optimize the design and performance of viral clearance processes using a customized approach and deliver the most suitable viral clearance service according to your budget, timeline, and specific requirements.
Service features
• Design of viral clearance studies (TSE clearance studies are also available)
• Establishment and verification of the process for viral clearance
• Multiple solutions to viral clearance
• Fully qualified facilities and instrumentation
• International regulatory support
Viral clearance testing is mandatory for investigational new drug (IND) submission and is a critical part of the biologic manufacturing process. Creative Biolabs provides viral clearance service compatible with ICH Q5A and other European, US and WHO regulatory guidelines.
Our viral clearance service on a diverse array of cGMP biopharmaceutical products including:
Monoclonal antibodies
Recombinant proteins
Glycoproteins
Blood-derived products
Cell therapy products
Vaccines
Animal-derived products
Medical devices
Methods of Viral Clearance Process
Viral Removal:
• Ethanol Precipitation
• Multiple Chromatography Systems
• Virus Removal Filtration
Viral Inactivation:
• Low or High pH
• Solvent/Detergent
• Chemical Treatment
• UV Treatment
• High Temperature Short Time(HTST) Treatment
• Pasteurization
To discuss your Viral Removal demands or to request a proposal, please contact us.
For Research Use Only. Not For Clinical Use.
